A novel device for left atrial appendage exclusion

Keiji Kamohara1, Kiyotaka Fukamachi, Yoshio Ootaki

  • 1Biomedical Engineering, The Cleveland Clinic Foundation, Cleveland, Ohio 44195, USA.

Insights

A novel device safely and effectively excludes the left atrial appendage, a common source of stroke in atrial fibrillation patients. This occlusion technique offers a promising new therapeutic option to reduce stroke risk.

Area of Science:

  • Cardiovascular Surgery
  • Medical Devices
  • Thrombosis Research

Background:

  • The left atrial appendage is a primary source of thromboemboli in patients diagnosed with atrial fibrillation.
  • Exclusion or excision of the left atrial appendage is a potential strategy to mitigate stroke risk in this patient population.

Purpose of the Study:

  • To evaluate the efficacy and safety of a novel device designed for left atrial appendage exclusion.
  • To assess the performance of this device in early and intermediate follow-up periods within a canine model.

Main Methods:

  • Eight mongrel dogs underwent implantation of a novel occlusion device at the left atrial appendage base via left thoracotomy on a beating heart.
  • Post-implantation evaluation included epicardial echocardiography, left atrial angiography, histologic inspection, and gross pathology at 7, 30, and 90 days.

Main Results:

  • Device implantation was successfully completed in all subjects without complications.
  • Echocardiographic and angiographic assessments confirmed complete and sustained exclusion of the left atrial appendage from circulation.
  • No instances of device migration or damage to adjacent cardiac structures were observed.

Conclusions:

  • The novel device facilitates rapid, reliable, and safe exclusion of the left atrial appendage.
  • This innovative device presents a new therapeutic avenue for reducing stroke risk in patients with atrial fibrillation.
Abstract